LDZX-50KAS Stainless Steel Vertical Autoclave with Manual Quick-Release Door and Integrated Pressure/Temperature Control

Overview

The LDZX-50KAS is a vertically oriented, manually operated autoclave engineered for reliable saturated steam sterilization under controlled pressure and temperature conditions. It operates on the fundamental principle of moist heat sterilization—utilizing pressurized saturated steam at temperatures exceeding 121 °C to achieve microbial inactivation, including spores, through protein denaturation and nucleic acid hydrolysis. Designed for routine laboratory, educational, and small-scale industrial applications, this unit complies with core sterilization performance criteria aligned with ISO 17665-1 (Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices) and supports GLP-compliant documentation workflows when integrated with external logging systems. Its vertical configuration optimizes floor space utilization while maintaining accessibility for loading standard laboratory glassware, stainless steel instruments, wrapped surgical packs, culture media bottles, and polymer-based labware.

Key Features

• Fully welded AISI 304 stainless steel construction throughout chamber, door, and outer jacket—resistant to corrosion, thermal fatigue, and repeated chemical exposure.
• Manual quick-release cam-lock door mechanism with ergonomic handwheel operation—enables rapid, tool-free opening and secure sealing without pneumatic or hydraulic assistance.
• Self-expanding silicone gasket system ensuring leak-tight integrity across operating cycles; maintains consistent compression under thermal expansion and pressure differentials.
• Dual-scale Class II pressure gauge (MPa and psi) with mechanical redundancy—provides real-time visual verification of chamber pressure during heating, sterilization hold, and cooling phases.
• Integrated safety interlock system preventing door opening when internal pressure exceeds 0.02 MPa; physically disables rotation until safe depressurization is confirmed.
• Automatic overpressure relief valve calibrated to activate within 0.145–0.165 MPa range—complies with ASME BPVC Section VIII Div. 1 requirements for pressure vessel safety devices.
• Low-water cutoff sensor with audible/visual alarm and automatic heater shutdown—prevents dry-firing and thermal damage to heating elements.
• LED status indicators for power-on, heating, sterilization, and cooling phases—supports unambiguous operational state recognition without requiring display interpretation.

Sample Compatibility & Compliance

The LDZX-50KAS accommodates a broad spectrum of load types, including but not limited to: unwrapped metal instruments, wrapped textile packs (e.g., gauze, drapes), borosilicate glassware (vials, flasks, pipettes), liquid media in sealed or vented containers, and heat-stable polymers (e.g., polypropylene centrifuge tubes). Load configurations must conform to established steam penetration principles—avoiding dense stacking, ensuring air removal via gravity displacement, and permitting uniform steam circulation. While the unit itself does not include automated cycle validation tools, its stable pressure/temperature profile enables users to perform IQ/OQ protocols per ISO 13485 and FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing. It meets national medical device sterilizer standards GB 8599–2008 (China) and serves as a validated platform for non-critical and semi-critical item processing in academic, pharmaceutical R&D, and food microbiology settings.

Software & Data Management

This model operates via electromechanical controls without embedded microprocessor-based software. All timing, temperature, and pressure regulation are achieved through analog thermostats, bimetallic pressure switches, and mechanical timers. Consequently, no firmware, network connectivity, or electronic data export capability is present. However, its deterministic behavior—repeatable cycle profiles, fixed ramp rates, and discrete phase transitions—facilitates manual recording and third-party data acquisition using external thermocouple loggers (e.g., compliant with ASTM E2251–22 for temperature mapping) and pressure transducers. Users implementing 21 CFR Part 11 compliance may integrate the unit into broader quality management systems via external validation documentation, paper-based batch records, and audit-trail-enabled environmental monitoring hardware.

Applications

• Sterilization of reusable surgical instruments and dental tools in teaching hospitals and training labs.
• Preparation of bacteriological growth media and agar plates in university microbiology departments.
• Decontamination of biohazardous waste prior to disposal in BSL-2 containment facilities.
• Heat sterilization of glassware, stainless steel forceps, and stainless trays used in cell culture and molecular biology workflows.
• Processing of food samples and packaging materials for shelf-life studies and pathogen challenge testing.
• Validation support for steam penetration studies in packaging development laboratories.

FAQ

Does the LDZX-50KAS support programmable cycles or digital scheduling?
No. It features fixed-cycle operation with manual start/stop controls and mechanical timers only.
Is it suitable for sterilizing liquids in sealed containers?
Yes, provided containers are designed for steam sterilization (e.g., vented bottles or autoclavable closures) and loaded according to gravity-displacement best practices to prevent boil-over.
What maintenance is required for long-term reliability?
Routine tasks include weekly gasket inspection and cleaning, monthly chamber interior descaling (using citric acid solution), annual calibration verification of the pressure gauge and temperature cut-off switch, and biannual safety valve functional testing.
Can it be installed in a standard laboratory electrical circuit?
Yes—its 220 V / 3.5 kW rating requires a dedicated 20 A circuit with proper grounding; no three-phase supply is needed.
Is third-party validation support available?
While the manufacturer provides technical specifications and dimensional drawings, IQ/OQ protocol development, installation qualification, and temperature mapping services must be performed by qualified external validation specialists or in-house QA teams.